Who Needs To Register?
Persons having possession of any radiation machine or accelerator are required to register with the Tennessee Division of Radiological Health (DRH). In general, the following types of equipment must be registered:
- Class I - Dental Radiation Machines: Includes all diagnostic equipment used exclusively for dental diagnostic procedures.
- Class II - Priority Two Medical Radiation Machines: Includes all diagnostic x-ray equipment not in Class III used exclusively for medical or veterinary diagnostic procedures.
- Class III - Priority One Medical Radiation Machines: Includes all diagnostic x-ray equipment used in radiologists' offices, orthopedic surgeons' offices and hospitals exclusively for medical diagnostic procedures.
- Class IV - Therapy Medical Radiation Machines: Includes all x-ray equipment with energies less than 0.9 MeV used for the purpose of medical or veterinary radiation therapy.
- Class V - Priority Two Industrial and Educational Radiation Machines: Includes closed-beam analytical radiation machines, gauges and industrial radiation machines used in shielded room or cabinet radiography.
- Class VI - Priority One Industrial and Educational Radiation Machines: Includes all x-ray machines used for industrial radiography and all open-beamed analytical x-ray machines not specifically included in Classes I, II, III, IV, V or VII.
- Class VII - Accelerators: Includes equipment designed for and used only for the production of x-rays of 0.9 MeV or greater and equipment capable of discharging nuclear particles into a medium external to the accelerating device.
State Regulations for Protection Against Radiation allows certain types of x-ray producing equipment, such as domestic television receivers and other electrical equipment, to be exempt from registration provided they produce radiation incidental to their use and the dose rate does not exceed 0.5 rem per year. Radiation producing machines in transit and radiation machines that are totally unusable except for salvage parts also are exempt from registration.
What Information Must I Provide?
For Classes I-VI, a completed Registration of X-ray Producing Equipment (Form RHS 8-4) must be submitted within 10 days after acquisition of the x-ray producing equipment. The form requires detailed information concerning the owner, possessor and person in charge of the x-ray equipment; the medical specialty of the possessor (if applicable), and specific information for each tubehead.
For Class VII x-ray producing equipment (accelerators), a completed Application for Certified Registration (Form RHS 8-8) must be submitted within 10 days after acquisition of the accelerator. The form requires detailed information concerning the applicant, location where the accelerator will be used and stored, description and proposed use of the accelerator, facility description, shielding evaluations, training program, and other information as required.
Completed registration forms may be submitted to XRay.Registration@tn.gov.
|Form description||Form Number
|Registration of X-Ray Producing Equipment||RHS 8-4 CN-0724|
|Application for Service Provider/X-Ray Machine Installer
||RHS 8-4a CN-0801|
|Application for Registration to Perform Radiation Machine Inspection||RHS 8-4b CN-0802|
|Application for Certified Registration||RHS 8-8 CN-1449|
Effective December 9, 2019, Chapter 0400-20-06 of "State Regulations for Protection Against Radiation" has been updated to eliminate the need for exemption for handheld x-ray devices and whole body scanners.
How Will My Application Be Processed?
Upon receipt of the completed registration form for tube Classes I-VI, the Division reviews the form for completeness, issues the registration along with an invoice for the appropriate fee, and sends them to the registrant. The review process normally takes less than one (1) day. The X-ray Registration is valid indefinitely; it does not expire.
Class VII machines (accelerators) must have a Certified Registration. Upon receipt of the appropriate registration form and fees, the Certified Registration application is reviewed for completeness. If necessary, the Division sends a deficiency letter to the applicant. The review process may generate more deficiency letters until an adequate response to the Division's concerns is received from the applicant. Upon submittal of the necessary information, a Certified Registration is issued. The entire Certified Registration process usually takes thee (3) to six (6) months. Certified Registrations are issued for a five-year renewable period.
What Fees Are Required?
An initial registration fee will be assessed after the submission of a completed registration. Additionally, an annual registration fee will be required each year as long as the radiation machine or service is subject to registration. These fees will be assessed in accordance with the Classification and Fee Schedule found below. Rule 0400-20-10-.24
- Class I: $85 per tube
- Class II: $195 per tube
- Class III: $286 per tube
- Class IV: $390 per tube
- Class V: $780 per tube
- Class VI: $1,170 per tube
- Class VII: $2,600 per machine. An initial review fee will be assessed $375 per nominal MeV, not to exceed $150,000
What Are My Rights And Responsibilities After Registration?
The registrant may proceed with the approved use of registered equipment. For Classes I-VI, the registration is not transferable. Changes such as address, ownership, possessor or location of use from that declared on the previous registration require the x-ray producing equipment to be re-registered. The registrant is required to follow State Regulations for Protection Against Radiation in the use of the equipment.
For Class VII machines (accelerators), the Certified Registration may be transferred in accordance with the rules and regulations and with the written consent of the Division and both parties. The Certified Registrant is required to follow the conditions of the Certified Registration and State Regulations for Protection Against Radiation. The Certified Registrant also has the right to request an amendment of the Certified Registration. Changes in the scope of authorized activities of the Certified Registration may require additional fees.
What Are The Division's Rights And Responsibilities After Registration?
The Division has the right to inspect the registrants as follows:
- Class I - once every four years
- Classes II and V - once every two years
- Classes III, IV, VI, and VII - once every year
Penalties for violations can reach up to $5,000 per day per violation.
The Division is responsible for regulating sources of radiation in order to protect the health and welfare of the people and environment of the State of Tennessee.
Whom Do I Contact For Applications, Assistance And Other Sources Of Information?
Registration forms and assistance may be obtained from the Supervisor of Registration Machine/Device Permitting - RI Evaluation at the Division of Radiological Health in Nashville.
Applicants may refer to the following publications:
- DRH Rule Chapter 0400-20-10-.24, Registration
- TCA § 68-23-101, et seq., 68-202-101, et seq., and 4-5-201 et seq.
- X-Ray Registration Informational Handout